BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 5 11MM

    MDR report key: 19716717 · Received July 10, 2024

    Report

    Report Number
    1038671-2024-02292
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    September 12, 2022
    Report Date
    November 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304636
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND LOSS OF RANGE OF MOTION OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6: CORRECTED MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: CONCOMITANT DEVICES: 6608156 02-020-11-0350 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 5. 6669627 02-012-60-1425 - TRU STEM EXT 14MM X 25MM. 6716473 200-02-35 - THREE PEG PATELLA 35MM. 6900839 02-022-45-5045 - TRULIANT TRAY, CEM SZ 5F/4.5T.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 15 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, TISSUE DAMAGE, REVISION SURGERY, POLYETHYLENE WEAR, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380483 TRULIANT TIB IMP PS INSERT SZ 5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304636

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.